Changes to the mitochondrial DNA in non-cancer cells induced by chemotherapy and the relation with fatigue in men with germ-cell cancer of the testis: a feasibility study.
Completed
- Conditions
- Fatigue in men with testicular cancer10027656
- Registration Number
- NL-OMON45432
- Lead Sponsor
- Interne Oncologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 37
Inclusion Criteria
-Men with metastatic germ cell cancer of the testis planned to receive three cycles of BEP chemotherapy (bleomycin, etoposide, cisplatin)
-Signed informed consent
Exclusion Criteria
-Received chemotherapy before
-Chronic Fatigue Syndrome or fibromyalgia
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>A decrease >=30% in the number of mtDNA molecules per cell AND/OR an increase of<br /><br>>=11 damage lesion per 10 kb in mtDNA of blood cells during chemotherapy<br /><br>(measurements 2 and 3) and three months after completing chemotherapy<br /><br>(measurement 4), compared to baseline (measurement 1).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The severity of physical fatigue and mental fatigue at baseline (measurement<br /><br>1), during chemotherapy (measurement 2 and 3), and three months after<br /><br>completing chemotherapy (measurement 4).<br /><br>Mitochondrial functioning in blood cells at baseline (measurement 1), during<br /><br>chemotherapy (measurement 2 and 3), and three months after completing<br /><br>chemotherapy (measurement 4).</p><br>